Technical Lead - Software as Medical Device (SaMD)

For our Medical Device Company we are recruiting for an expert in App Development to support their expanding development of "Software as a Medical Device" (SaMD),

You will be a recognized expert for the development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD.

Responsibilities:

* The role includes early phase development activities, the management and monitoring of software development at external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer. * Technical leadership for the software development of mobile and/or web applications classified as SaMD * Providing software/systems life cycle expertise within a broader cross‐functional drug product development team * Supporting the standardization of the entire SaMD life cycle management process in order to utilize cross‐product synergies * Leading the collaboration with external development partners: o Support supplier selection, auditing and approval o Elaboration of development plans and contracts for upcoming projects o Monitor work progress according to plan o Monitor, support and challenge technical development and deliverables as well as change, test and release strategies o Support the deployment and implementation of a sustainable Product Life Cycle process in close collaboration with external and internal partners and stakeholders * Leading and/or supporting cross functional project teams during development, review and submission of regulatory dossiers * Leading risk management activities * Planning and monitoring of design verification activities * Leading and authoring technical documentation * Ensuring a high quality Design History File * Supporting the improvement of the SaMD QMS

Requirements:

* MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies * Experience in project / program management of complex projects * Autonomous and independent working style with at least 7 years of experience as technical project management of projects with safety critical applications in a regulated environment * Team player who works efficiently in interdisciplinary teams * Experience in designing innovative software and systems architectures * Analytical thinking and problem‐solving capability * Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set‐up and test automation * Considerable experience of managing external suppliers * In addition to outstanding project management and interpersonal skills, a strong background in software development and lifecycle management, as well as the use and implementation of platform technologies, is crucial for this role. The successful candidate will play a critical role in the support and sustainable expansion of the SaMD area.

Kontact: or call +41 (0) 44 215 2051

Michael Bailey International is acting as an Employment Business in relation to this vacancy.